In recent years, in fields of food inspection, development and evaluation of new medicines, and the like, guidelines called good laboratory practice (GLP) and good manufacturing practice (GMP) have been introduced in order to secure the reliability of measurement results. In GLP/GMP, strict guidelines are provided for management of data containing setting conditions and results of examination and inspection, and the validity of an analyzing apparatus or an analyzing system itself used for measurement is required to be proved. Then, in order to enable objective evaluation of the validity thereof, the entire activity from planning to implementation of an analysis is required to be documented.
Examples of the adopted methods for proving the validity of an analyzing apparatus include installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ). The installation qualification (IQ) is intended to check whether the analyzing apparatus is installed as designed or as defined in its specifications and under appropriate environments. Further, the operational qualification (OQ) and the performance qualification (PQ) are intended to check, through various examinations, whether the installed apparatus satisfies required performance.
For example, the operational qualification (OQ) is implemented in the following procedures (FIG. 1). First, a user requests an analyzing apparatus manufacturer to do validation work. The apparatus manufacturer which has received this request creates a qualification plan document. The apparatus manufacturer prepares in advance standard instructions 11 of plan documents and implementation procedure manuals for such qualification, with regard to various units used for an analyzing apparatus. The apparatus manufacturer that has received the request from the user selects, from among the various standard instructions, a basic plan document 12 and an implementation basic procedure manual 13 matched with an analyzing apparatus system 10 supplied to the user.
The analyzing apparatus 10 supplied to the user may be used without any change, and the apparatus configuration may be changed so as to suit an intended analysis purpose of the user. Further, qualification parameters and qualification reference values are generally different for each user.
Accordingly, the user and the apparatus manufacturer consult with each other, whereby a qualification plan document 22 and a qualification implementation procedure manual 23 corresponding to validation work to be done this time are created on the basis of the basic plan document 12 and the implementation basic procedure manual 13 corresponding to a general analyzing apparatus system 10, general qualification parameters, and general qualification reference values. A validation worker of the user (or the apparatus manufacturer) implements qualification examination (validation) of a validation target analyzing apparatus 20 on the basis of the qualification implementation procedure manual 23 thus created. Examination results are documented as a report concerning the qualification, are checked and approved also by the user, and are stored as a result document.
In validation work on an analyzing apparatus, the apparatus is manually operated one by one, and hence such validation work requires enormous time and effort. In view of this, systems for supporting such work have been developed up to now. For example, a system described in Patent Document 1 achieves power saving and automation of validation work concerning a calculation function and a report output function of an analyzing apparatus.